Search Results

The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen Anal Irrigation System is indicated for use by children (2 years -

The Peristeen™ Anal Irrigation (PAI) System is a Class II device intended for intermittent use that facilitates emptying of the colon/bowel in patients with neurogenic bowel dysfunction. The PAI system consists of a single-use irrigation catheter that incorporates an inflatable balloon to keep the catheter in place during the procedure and retain the water that flows into the colon. The rectal catheter is non-sterile, intended for single-use, and packaged and labeled accordingly. The other components may be used multiple times; usage guidelines are detailed in the labeling. All System components are also provided separately in various accessory packages.

The provided document is a 510(k) premarket notification for the Peristeen™ Anal Irrigation System. It states that no changes have been made to the device design, materials, components, technological characteristics or manufacturing processes of the subject device compared to the predicate. The only change being effected is the release of an updated Instructions For Use (IFU).

Therefore, the document explicitly states: "As such, testing for Performance, Shelf Life and Biocompatibility was not deemed necessary to support substantial equivalence. No clinical testing was performed, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Because no new performance testing was conducted for this submission, the document does not contain the information required to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Ask a specific question about this device